Monthly Report: New Drug Approvals in China | Sept. 2021

Editor's Notes: New drugs in this article refer to

Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China*.

*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.

Perhaps you would like to know the drug classifications in China:

In Sept. 2021, China's NMPA granted 13 new drug approvals:

1. Recombinant Human Growth Hormone for Injection

1	Generic Name	Recombinant Human Growth Hormone for Injection
2	Brand Name	安苏萌 (Pinyin: An Su Meng)
3	Registration Classification	Class 3.2 therapeutic biological product
4	Application Type	Marketing authorization
5	Marketing Authorization Holder (MAH)	Anhui Anke Biotechnology (Group) Co., Ltd.
6	Approval Date	Sept. 13, 2021
7	Time from Application Acceptance to Approval	240 days
8	Priority Review	Yes (reason: pediatric drug)
9	Target	Growth hormone receptor (GHR)
10	Indication(s)	For idiopathic short stature. (1) For children: Growth disorders caused by the deficiency of endogenous growth hormone, Turner syndrome, or chronic renal insufficiency. For the treatment of Prader-Willi Syndrome (PWS): facilitate growth and improve body composition. The diagnosis of PWS should be done through proper genetic testing. (2) For adults: As an alternative therapy, it can be used to treat adults with severe growth hormone deficiency (GHD). Adults with severe GHD refer to adult patients with hypothalamus disorder, pituitary gland disorder or both, and the deficiency of at least one pituitary hormones (except for prolactin). The adult patients should receive a single growth hormone (GH) stimulation test to confirm or exclude GH deficiency. Adult patients should receive two GH stimulation tests if they only had GH deficiency during childhood without disorders of the hypothalamus or pituitary gland or evidence of their heads having got radiated. For patients whose their insulin-like growth factor 1 (IGF-1) concentration's standard difference score is known below 2, they can consider taking single GH stimulation test for only one time. GH stimulation tests shall have strict cut-off values.
11	Notes	First biosimilar in China

2. Dupilumab Injection

1	Generic Name	Dupilumab Injection
2	Brand Name	达必妥 (Dupixent)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	Supplemental application
5	MAH	Sanofi-Aventis Groupe
6	Approval Date	Sept. 18, 2021
7	Time from Application Acceptance to Approval	257 days
8	Priority Review	No
9	Target	Interleukin 4 Receptor (IL4R)
10	Indication(s)	Dupixent is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
11	Notes	First biosimilar in China

3. Dupilumab Injection

1	Generic Name	Dupilumab Injection
2	Brand Name	达必妥 (Dupixent)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	Drug import.
5	MAH	Sanofi-Aventis Groupe
6	Approval Date	Sept. 9, 2021
7	Time from Application Acceptance to Approval	313 days
8	Priority Review	Yes (reason: pediatric drug)
9	Target	Interleukin 4 Receptor (IL4R)
10	Indication(s)	Dupixent is indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
11	Note	First biosimilar in China

4. Pembrolizumab Injection

1	Generic Name	Pembrolizumab Injection
2	Brand Name	可瑞达 (Keytruda)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	Drug import
5	MAH	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
6	Approval Date	Sept. 3, 2021
7	Time from Application Acceptance to Approval	270 days
8	Priority Review	No
9	Target	Programmed cell death protein 1 (PD-1)
10	Indication(s)	Keytruda is indicated for the treatment of unresectable or metastatic melanoma after the failure of first-line treatment. This indication is granted conditional approval in China based on the overall response rate (ORR) result of a single-arm clinical trial. Whether this indication will receive full approval depends on the ongoing confirmatory clinical trial which explores whether the therapy can realize the long-term clinical value for patients in China.

5. Relmacabtagene Autoleucel Injection

1	Generic Name	Relmacabtagene Autoleucel Injection
2	Brand Name	倍诺达 (Carteyva)
3	Registration Classification	Class 1 therapeutic biological product
4	Application Type	Marketing authorization
5	MAH	JW Therapeutics (Shanghai) Co., Ltd.
6	Approval Date	Sept. 3, 2021
7	Time from Application Acceptance to Approval	416 days
8	Priority Review	Yes (qualified for conditional approval)
9	Target	B-lymphocyte antigen CD19
10	Indication(s)	For the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. The applicable r/rLBCL includes diffuse large B-cell lymphoma (DLBCL), DLBCL transformed from follicular lymphoma, grade 3b follicular lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphomas (HGBLs) with MYC and BCL2 and/or BCL6 rearrangements (so-called double/triple-hit lymphomas). NOT for treating primary central nervous system lymphoma (PCNSL).

6. Infliximab for Injection

1	Generic Name	Infliximab for Injection
2	Brand Name	安佰特 (Pinyin: An Bai Te)
3	Registration Classification	Class 2 therapeutic biological product
4	Application Type	Marketing authorization
5	MAH	Zhejiang Hisun Pharmaceutical Co., Ltd.
6	Approval Date	Sept. 28, 2021
7	Time from Application Acceptance to Approval	486 days
8	Priority Review	No
9	Target	Tumor Necrosis Factor (TNF)
10	Indication(s)	Rheumatoid arthritis (RA) in combination with methotrexate: reducing signs and symptoms, improving patient's physical function, and preventing possible disability in patients with moderate-to-severe active disease. Active Crohn's disease in patients aged over six who have had an inadequate response to conventional therapy: reducing signs and symptoms, inducing and maintaining clinical remission, inducing membrane healing in adult patients, and making adult patients use less or no cortical hormone. Fistulas in Active Crohn's disease: reducing enterocutaneous/rectovaginal fistulas, inducing and maintaining the fistula's closure, and reducing signs and symptoms. Ankylosing spondylitis: reducing signs and symptoms in patients with active disease, increasing range of motion, and improving body functions. Plaque psoriasis: for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy (e.g. ciclosporin A therapy, methotrexate therapy, photochemotherapy) and when they have had an inadequate response, or are intolerant to, or have contraindications to other systemic therapies. Infliximab can only be administered to patients who will be closely monitored by and have regular follow-up visits with physicians. Ulcerative colitis in adults: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and reducing or eliminating the use of corticosteroid in adult patients with moderate-to-severe active ulcerative colitis (UC) who have had an inadequate response, or are intolerant to, or have contraindications to conventional therapy.

7. Tofacitinib Citrate Sustained-release Tablets

1	Generic Name	Tofacitinib Citrate Sustained-release Tablets
2	Brand Name	Xeljanz
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Drug import
5	MAH	Pfizer Inc.
6	Approval Date	Sept. 9, 2021
7	Time from Application Acceptance to Approval	458 days
8	Priority Review	No
9	Target	Janus kinase; Cytochrome P450 2C19; Cytochrome P450 Family 3 Subfamily A Member 4; Tyk2 tyrosine kinase; Serum albumin; Tyrosine-protein kinase JAK1; Tyrosine-protein kinase JAK2; Tyrosine-protein kinase JAK3.
10	Indication(s)	/

8. Choline Fenofibrate Sustained-release Capsules

1	Generic Name	Choline Fenofibrate Sustained-release Capsules
2	Brand Name	/
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Drug import
5	MAH	Abbott Laboratories Limited.
6	Approval Date	Sept. 9, 2021
7	Time from Application Acceptance to Approval	461 days
8	Priority Review	No
9	Target	Peroxisome Proliferator Activated Receptor Alpha (PPARA)
10	Indication(s)	/

9. Ambroxol Hydrochloride Drops

1	Generic Name	Ambroxol Hydrochloride Drops
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	Marketing authorization
5	MAH	Qinhuangdao Aihui Pharmaceuticals Co., Ltd.
6	Approval Date	Sept. 3, 2021
7	Time from Application Acceptance to Approval	538 days
8	Priority Review	No
9	Target	Thiocyanate hydrolase subunit alpha; Glucosylceramidase
10	Indication(s)	For treating patients, including young children, whose phlegm is too thick to expectorate. The medication package insert or the drug label shall include clear instructions on the dosage and usage for children.
11	Notes	First generic in China

10. Cefcapene Pivoxil Hydrochloride Granules

1	Generic Name	Cefcapene Pivoxil Hydrochloride Granules
2	Brand Name	/
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Drug import
5	MAH	Shionogi & Co., Ltd.
6	Approval Date	Sept. 13, 2021
7	Time from Application Acceptance to Approval	561 days
8	Priority Review	Yes (reason: pediatric drug)
9	Target	Bacterial penicillin binding protein
10	Indication(s)	For pediatric patients. For treating infections caused by cefcapene-sensitive bacteria, including staphylococcus, streptococcus, streptococcus pneumoniae, Moraxella catarrhalis, Escherichia coli, citrobacter, Klebsiella, enterobacter, Serratia, proteobacteria, Morganella morganii, Providencia, haemophilus influenzae, peptostreptococcus, bacteroides, Prevotella Shan and Collins (except Prevotella bivia), or cutibacterium acnes. The infections mentioned above include dermatitis of the superficial or deep layers of the skin, lymphangitis, pyoderma gangrenosum, laryngopharyngitis, tonsillitis (including peritonsillitis and peritonsillar abscess), acute bronchitis, pneumonia, cystitis, nephropyelitis, tympanitis, sinusitis, and scarlet fever.

11. Pregabalin Sustained-release Tablets

1	Generic Name	Pregabalin Sustained-release Tablets
2	Brand Name	/
3	Registration Classification	Class 2.2 chemical drug
4	Application Type	Marketing authorization
5	MAH	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
6	Approval Date	Sept. 28, 2021
7	Time from Application Acceptance to Approval	734 days
8	Priority Review	No
9	Target	Gamma-aminobutyric acid receptor; Voltage-dependent calcium channel subunit alpha-2/delta-1; Calcium channel; Gamma-Aminobutyric Acid Type A Receptor Subunit Alpha2; Gamma-aminobutyric acid receptor subunit delta.
10	Indication(s)	/

12. Entecavir Granules

1	Generic Name	Entecavir Granules
2	Brand Name	/
3	Registration Classification	Class 2.2 chemical drug
4	Application Type	Marketing authorization
5	MAH	Hunan Huana Grand Pharmaceutical Factory Co., Ltd.
6	Approval Date	Sept. 16, 2021
7	Time from Application Acceptance to Approval	959 days
8	Priority Review	Yes (reason: pediatric drug)
9	Target	DNA polymerase
10	Indication(s)	For the treatment of chronic hepatitis B virus infection in adult patients with active viral replication and evidence of either persistent elevation in serum aminotransferases (ALT) or histologically active disease. For the treatment of 2-to-18-year-old pediatric patients with chronic HBV-infected compensatory hematologic diseases who use therapeutic nucleotides for the first time, with evidence of active replication and persistent elevations in serum aminotransferases (ALT), or with moderate-to-severe infections, or with histological evidence of fibrillation.

13. Levornidazol and Sodium Chloride Injection

1	Generic Name	Levornidazol and Sodium Chloride Injection
2	Brand Name	/
3	Registration Classification	Class 2.1 chemical drug
4	Application Type	Marketing authorization
5	MAH	Beijing Jinyaoyuan Medicine Research Institute
6	Approval Date	Sept. 13, 2021
7	Time from Application Acceptance to Approval	1,134 days
8	Priority Review	No
9	Target	Deoxyribonucleic acid
10	Indication(s)	1. For the treatment of infectious diseases caused by Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides wdgatus, Clostridium, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, Bacteroides melaninogenicus, Fusobacterium, Capnocytophaga, Oribaculum catoniae, or other sensitive anaerobic bacteria. The diseases include (1) Abdominal infections: peritonitis, intra-abdominal abscess, liver abscess, etc. (2) Pelvic inflammatory diseases: endometritis, myometritis, fallopian tube or ovary abscess, pelvic soft-tissue infection, haemophilus vaginitis, etc. (3) Oral infections: periodontitis, peripheral inflammation, pericoronitis, acute ulcerative gingivitis, etc. (4) Surgical infections: wound infection, cutaneous abscess, pressure ulcer infection, cellulitis, gas gangrene, etc. (5) Brain infections: meningitis, cerebral abscess, etc. (6) Septicemia, bacteremia, or other severe infections caused by anaerobic bacteria.

If you need details of the approved drugs listed above or drug registration procedures in China, welcome to send an email to contact@chemlinked.com.